Your #1 Choice for Pharmacovigilance & Regulatory Affairs Services in Africa

Let's Strengthen Your Pharmacovigilance Operations

Whether you are building a new pharmacovigilance system, entering African markets, or strengthening regulatory compliance, IntraHub Africa is ready to support you.

Pharmacovigilance ADR Reporting Regulatory Affairs Drug Safety NAFDAC Compliance Signal Detection ICSR Management Pharmacovigilance ADR Reporting Regulatory Affairs Drug Safety
Pharmacovigilance ADR Reporting Regulatory Affairs Drug Safety NAFDAC Compliance Signal Detection ICSR Management Pharmacovigilance ADR Reporting Regulatory Affairs Drug Safety
IntraHub Africa team
Regulatory compliance in Africa

10+

African Markets Covered

About IntraHub Africa

Building Africa's Drug Safety Infrastructure

At IntraHub Africa, our mission is to deliver scalable, compliant, and user-centric solutions that simplify drug safety reporting, empower stakeholders, and protect patients. We are committed to bridging the gap between pharmaceutical companies, regulatory bodies, and healthcare professionals through advanced technology and expert services.

What We Do

End-to-end drug safety and regulatory compliance across Africa

Pharmacovigilance Services

PV system setup, ICSR case management, signal detection, and aggregate reporting aligned with NAFDAC, WHO, EMA, ICH, and FDA requirements.

Regulatory Affairs

Product registration, dossier preparation (CTD/eCTD), post-approval variations, GMP inspection support, and regulatory strategy across African markets.

Training & Capacity Building

Accredited workshops, e-learning, and certification programs in pharmacovigilance and regulatory affairs — on-site, online, or through IntraHub LMS.

Technology Platforms

Purpose-built software that replaces spreadsheets, email chains, and paper files: IntraVigi Safety Database, the IntraVigi Reporting App, PV CompliSure, and IntraHub LMS.

Why Choose IntraHub?

The pharmacovigilance partner built for Africa

We focus on practical, technology-driven solutions with personalised guidance to ensure your drug safety operations are fully compliant and future-ready.

Pharmaceutical Companies Served

50+

Pharmaceutical companies, CROs, and regulatory stakeholders trust IntraHub Africa across Nigeria and West Africa.

Real-Time Pharmacovigilance

ICSRs Processed Annually

We handle end-to-end ICSR case management with full E2B(R3) compliance and regulatory submission capabilities.

  • E2B(R3) Compliant
  • Multi-tenant

Local Expertise, Global Standards

With our in-depth understanding of local pharmacovigilance rules and global guidelines, you can confidently ensure compliance.

Cutting-Edge Technology

We leverage AI-driven solutions to automate ADE reporting, signal detection, and compliance, giving you the most advanced tools for drug safety.

Tailored Solutions

We know your needs are unique. We focus on understanding your challenges to create tailored pharmacovigilance solutions that work for you.

Continuous Improvement

We are committed to staying ahead of the curve, constantly updating our knowledge and technology to reflect the latest regulations and best practices.

IntraVigi Safety Database

Enterprise PV platform: full-scale ICSR management, E2B(R3) compliance, regulatory submissions, QMS integration, and executive dashboards — built for African regulatory realities.

IntraVigi Reporting App

The public safety gateway: patients, healthcare professionals, and the public can submit ADR reports easily and securely — with AI chatbot-guided reporting flowing directly into IntraVigi Safety Database.

PV CompliSure

AI-powered PV self-assessment platform. Evaluate your PV system against requirements across multiple African countries, identify risks before inspections, and track regulatory developments.

IntraHub LMS

Learning management system delivering accredited pharmacovigilance and regulatory affairs courses. Self-paced, certificate-backed, and designed around the real work African PV professionals do.

How We Work

Four clear steps to a stronger pharmacovigilance system

Step 01

Free Consultation

A no-obligation call to understand your products, your markets, and your current pain points. We listen first.

  • Understand your specific regulatory environment and product portfolio.

Step 02

Needs Assessment

We review your existing PV systems, SOPs, and compliance framework — identifying gaps, quantifying risk, and documenting what needs to change.

  • Gap analysis against NAFDAC, WHO, ICH, EMA, and FDA requirements.

Step 03

Tailored Roadmap

A clear plan with timelines, deliverables, and regulatory milestones. We define scope together — no jargon, no surprises.

  • Regulatory milestones mapped and communicated clearly.

Step 04

Implementation & Ongoing Support

We build or optimise your PV system, deploy our technology platforms, train your team, and stay with you for ongoing monitoring, reporting, and audit readiness.

  • Continuous support for monitoring, reporting, and regulatory audits.
Why Partner With Us

Elevate your pharmacovigilance strategies today

500+

Professionals trained across West Africa through accredited workshops and our IntraHub LMS platform

Regulatory Compliance Rate

98%

Clients who partner with IntraHub Africa achieve and maintain full compliance with local and international pharmacovigilance requirements.

Enhanced Patient Safety Reduced Regulatory Risk Operational Efficiency Market Competitiveness Audit Readiness NAFDAC Compliance WHO Standards
Enhanced Patient Safety Reduced Regulatory Risk Operational Efficiency Market Competitiveness Audit Readiness NAFDAC Compliance WHO Standards
Enhanced Patient Safety Reduced Regulatory Risk Operational Efficiency Market Competitiveness Audit Readiness NAFDAC Compliance WHO Standards
Enhanced Patient Safety Reduced Regulatory Risk Operational Efficiency Market Competitiveness Audit Readiness NAFDAC Compliance WHO Standards
Our Testimonials

Trusted by pharmaceutical companies across Africa

We're proud to support our clients on their pharmacovigilance and regulatory affairs journey. Here's what they say about their experience with IntraHub Africa.

" Before partnering with IntraHub, our PV system had significant gaps. They identified every compliance risk, built us a clear roadmap, and deployed IntraVigi seamlessly. "

Dr. Adaeze Okafor

Head of Regulatory Affairs, Pharma Co.

" IntraHub's training programme transformed our team's understanding of pharmacovigilance. The IntraHub LMS is practical, accredited, and built around real African PV challenges. "

Emeka Nwosu

PV Manager, CRO

" PV CompliSure gave us complete visibility into our compliance posture across three markets before a scheduled NAFDAC inspection. We were fully prepared. "

Fatima Aliyu

Drug Safety Officer

Ready to Elevate Your Pharmacovigilance Strategies?

Partner with IntraHub Africa today

Embark on a journey towards enhanced patient safety, reduced regulatory risk, and stronger market competitiveness — with a team built for Africa.

Enhanced Patient Safety

Safeguard patients and boost confidence in your products with reliable drug safety monitoring systems.

Reduced Regulatory Risk

Achieve full compliance with local and international requirements, avoiding costly penalties and delays.

Optimised Efficiency

Simplify your pharmacovigilance and regulatory workflows, freeing up valuable time and resources.

Stronger Market Position

Position your brand as a leader in responsible drug development and marketing across African markets.

  • Free initial consultation
  • No hidden fees or surprises
  • Ongoing support after implementation
Frequently Asked Questions

Your questions about pharmacovigilance, answered

Find clear answers to the most common questions about our pharmacovigilance and regulatory affairs services, technology, and process.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. It ensures medicines on the market are continuously monitored for safety.

We work with NAFDAC, WHO, EMA, ICH, and FDA requirements. Our team stays continuously updated on local and international regulatory developments across African markets.

Yes. Our Regulatory Affairs team handles product registration, dossier preparation (CTD/eCTD), post-approval variations, and regulatory strategy specifically designed for African market entry.

We provide four purpose-built platforms: IntraVigi Safety Database (enterprise PV), IntraVigi Reporting App (public ADR reporting), PV CompliSure (AI-powered compliance assessment), and IntraHub LMS (accredited PV training).

ADR reports can be submitted through the IntraVigi Reporting App — available to patients, healthcare professionals, and the general public. Reports can be submitted manually or through our AI chatbot-guided reporting flow, and feed securely into the IntraVigi Safety Database.

Latest Insights

Pharmacovigilance news, regulation updates & expert insights

Stay current with in-depth insights, emerging regulatory changes, and important drug safety updates relevant to African pharmaceutical markets.


Trusted By